澎立檢測是獨立的第三方醫療器械檢測臨床前動物實驗一站式服務平臺,是全國首家醫療器械領域獲得CNAS認證的第三方大動物實驗中心。技術團隊主要實驗人員均具有10年以上醫療器械行業工作經驗。現有設備:通用?IGS330?DSA,飛利浦?EPIQ7C?四維超聲,西門子心腔內超聲ICE;OCT系統;骨科小型C臂機等;擁有超過4500平方米的標準動物飼養區:配備多功能手術區,可同時開展介入手術,無菌植入手術及急性培訓手術。服務包括:動物實驗方案設計與法規咨詢、產品可行性分析與驗證設計、臨床前動物實驗測試與研究、病理學及藥代動力學分析研究、臨床申報和注冊申報支持、醫師培訓服務、上市推廣支持服務。
PharmaLegacy?Diagnostic?Laboratories?(Shanghai)?Co.,?Ltd.?is?a?pre-clinical?large?animal?experiment?facility.?PharmaLegacy?Diagnostics?focus?on?high-risk?medical?device?testing?in?preclinical?area,?and?provide?one-stop?services.?The?operation?follows?international?GLP?regulations/guidelines,?AAALAC?standards.?PharmaLegacy?Diagnostics?has?filed?China?National?Accreditation?Service?for?Conformity?Assessment?and?got?the?certification,?No.:?CNAS?LA0011..?
PharmaLegacy?Diagnostics?focus?on?the?preclinical?animal?tests,?including?study?protocol?design,?related?regulatory?consultation,?animal?experiment?tests,?pathology?/pharmacokinetic?analysis,?and?pre-market?support.?Scopes?cover?cardiovascular,?intracranial,?osseous/dental?degradable?implants,?active?implantable?medical?devices,?and?drug?delivery?systems,?etc.